Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, announced today that it has reached its target enrollment of 12,750 patients in ECLIPSE (Evaluation of ctDNA LUNAR Assay In an Average Patient Screening Encounter), a registrational study to evaluate the performance of its LUNAR™-2 blood test to detect colorectal cancer (CRC) in average-risk adults.

Subject to positive study results, the number of patients currently enrolled in ECLIPSE is targeted to support a premarket approval (PMA) submission to the U.S. Food and Drug Administration in 2022.

“Colorectal cancer screening rates have remained stubbornly low due to the nature of current screening methods. New modalities in colorectal cancer screening, such as a routine, accurate blood test like the one being studied in the ECLIPSE study, has the potential to increase screening rates dramatically,” said AmirAli Talasaz, Guardant Health co-CEO. “Reaching this significant enrollment milestone highlights our ability to successfully run one of the largest cancer screening studies of its kind and gives us tremendous confidence in initiating large registrational studies in other cancer types, including the SHIELD screening study to detect lung cancer. It is also a testament not just to our team’s perseverance, but also to the commitment of our clinical researchers and the generosity of those enrolled in the study.”

Today, it is estimated that 1 in 3 adults in the U.S. does not adhere to national CRC screening recommendations even though regular screening for colorectal cancer has been shown to improve survival rates.1,2 Increasing screening rates to 80% from current levels could reduce the number of people diagnosed with CRC by 22% by 2030.3 However, current screening methods are time consuming and, in the case of a colonoscopy, invasive. LUNAR-2 is intended to improve CRC screening rates by offering a simple blood test that overcomes barriers associated with current testing methods and facilitates access to screening tests to more individuals and communities where access may be limited.

“Given the importance of this study and the size of the cohort, we’re grateful Guardant Health has been able to enroll 12,750 study participants in just over two years during a global pandemic,” said William M. Grady, M.D., Professor, Clinical Research Division, Fred Hutchinson Cancer Research Center. “We look forward to evaluating the data from the ECLIPSE study to increase our understanding of blood-based screening in patients at average risk for colorectal cancer.”

ECLIPSE is a prospective, multi-site registrational study to evaluate the performance of the company’s LUNAR-2 blood test to detect colorectal cancer in individuals aged 45-84 in the U.S. who are at average risk for colorectal cancer, including those who have historically been underrepresented in clinical research and identify as Native American and Black or African American.

Source: Company Press Release